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Registry Study of Assistive Devices, Medicines and Healthcare Measures in ALS, SMA and Other Neurological Diseases.

A

Ambulanzpartner Soziotechnologie (APST)

Status

Enrolling

Conditions

Amyotrophic Lateral Sclerosis

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05852418
EA1/219/15

Details and patient eligibility

About

This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with Amyotrophic lateral sclerosis (ALS), Spinal muscular atrophy (SMA) and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes.

Full description

This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with ALS, SMA and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes. The collected data include clinical characteristics, medical history, assessment scales, such as ALS functional rating scale-revised (ALSFRS-R), prognosis indicators, such as ALS progression rate, biomarker data, such as serum Neurofilament light chain (sNfL), genetic data, such as the mutation status of SOD1, FUS, c9orf72, TARDBP in ALS, SMN1 in SMA patients, innovative drugs such as Tofersen, Nusinersen, Risdiplam, as well as symptomatic drugs, patient-reported outcome data being captured using questionnaires and established clinical scales on medication expectation and treatment satisfaction.

Enrollment

25,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Diagnosis of a chronic neurological disease -

Exclusion Criteria: Lack of cooperation and unwillingness to store and share medical data collected in the registry study

Trial design

Trial documents
1

Trial contacts and locations

16

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Central trial contact

Senthil Kumar Subramanian, Dr.; Thomas Meyer, Prof. Dr.

Data sourced from clinicaltrials.gov

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